跳至主要内容
临床试验/NCT03945968
NCT03945968招募中不适用

The Role of Concomitant Diseases in Postoperative Complications Risk Stratification - a Prospective Observational Multi-center Cohort Study

Russian Federation of Anesthesiologists and Reanimatologists37 个研究点 分布在 1 个国家目标入组 16,000 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
16,000
试验地点
37
主要终点
incidence of postoperative complications

研究概览

简要总结

Study is conducted to assess the prevalence and structure of comorbidity among patients undergoing abdominal surgery and produce the stratification of the risk of postoperative complications by identifying independent predictors for its development.

详细描述

Advances in modern anesthesiology have significantly reduced the risk of anesthesia compared to the last century, however, the level of perioperative hospital mortality of planned operations at the moment is on average about 0.5% (ISOS group, 2016). Weiser et al. (2016) estimated that more than 313 million adults worldwide are subject to surgery each year. Thus, the number of deaths may result in several million each year worldwide. However, the study of the mortality risk is associated with certain difficulties, because over the past half century, this figure has decreased a hundred times and the study requires studies that include a large number of participants.

Current research focuses on other outcome criteria - postoperative complications. Thus, anesthetic risk often refers to the risk of postoperative complications. The frequency of these complications varies in a wide range, ranging from 3 to 18 % (Gawande AA, 1999, Kable AK, 2002, Malik OS, 2018). The differences in the data are explained by the lack of clear definitions and differences in the design of studies, but the fact that the development of postoperative complications increases the risk of death several times (ISOS group, 2016) can be considered undoubted. However, despite the importance of this issue, in modern literature there is no clear idea of what is considered a high risk and which of the patients corresponds to this category.

Understanding whether a patient is at high risk is an essential task - it allows you to obtain meaningful informed consent of the patient, as well as to understand whether to apply strategies for the prevention of complications (targeted infusion therapy, protective respiratory support, especially monitoring in the postoperative period, etc.).

Attempts at preoperative risk stratification have been made for many decades, some scales estimate the initial physical status (ASA scale) (Young J, 2015) and predict mortality, others estimate the risk of specific complications (Lee index, respiratory risk scale, etc.) .

Scales including intraoperative and postoperative parameters such as the POSSUM series of scales (Whiteley MS, 1996) are also being developed. The analysis shows that in routine clinical practice, these scales are not used very often, due to their limitations: subjectivity, technical complexity and often - low specificity and sensitivity.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • surgical interventions on the abdominal organs,
  • 1-3 ASA physical status class

排除标准

  • the inability to assess the factors included in the study,
  • acute massive blood loss, aspiration,
  • bronchospasm,
  • anaphylactic reactions,
  • malignant hyperthermia

结局指标

主要结局

incidence of postoperative complications

时间窗: 7 days after surgery

Postoperative complications (according to the definitions of ESA-SCICM, 2015) 1. Acute kidney damage 2. ARDS 3. The failure of the anastomose 4. Arrhythmias 5. Cardiac arrest 6. Cardiogenic pulmonary edema 7. Postoperative delirium 8. Myocardial infarction 9. Pneumonia 10. Paresis of the intestine 11. Postoperative bleeding 12. Pulmonary thromboembolism 13. Stroke 14. Wound infection NSQIP complications: 1. Acute respiratory failure 2. Unplanned reintubation 3. Sepsis/septic shock 4. Wound dehiscence 5. Postoperative transfusion

次要结局

  • mortality after abdominal surgery(30 days)

研究者

发起方
Russian Federation of Anesthesiologists and Reanimatologists
申办方类型
Other
责任方
Principal Investigator
主要研究者

Igor Zabolotskikh

Head of guidelines and clinical stгdies commettee

Russian Federation of Anesthesiologists and Reanimatologists

研究点 (37)

Loading locations...

相似试验